Efficacy and safety of lurasidone in adolescents and young adults with schizophrenia: Pooled analysis of double-blind, placebo-controlled 6-week studies

Abstract

Introduction

Onset of schizophrenia commonly occurs during late adolescence or early adulthood and is often characterized by greater symptom severity and impairment.

Objectives

To evaluate the efficacy and safety of lurasidone in the treatment of acute schizophrenia in adolescents and young adults.

Methods

The 4 studies in this pooled analysis used similar study designs. Patients (ages 13-25 years) were randomized to 6 weeks of double-blind, placebo-controlled treatment with once-daily lurasidone (37 mg, 74 mg, 111 mg, 148 mg). The primary outcome was endpoint change in the Positive and Negative Syndrome Scale (PANSS) total score; secondary measures included the Clinical Global Impression, Severity scale (CGI-S).

Results

The safety population consisted of 537 patients; 79.1% completed the studies. Treatment with lurasidone was significant (P<0.001) at Week 6 endpoint for change in the PANSS total score, with higher effect sizes (ES) at higher doses (37 mg, 0.53; 74 mg, 0.57; 111 mg, 0.67; 148 mg, 1.35); significance was also observed for change in the CGI-S (37 mg, 0.51; 74 mg, 0.49; 111 mg, 0.57; 148 mg, 1.75). For lurasidone (combined doses), 3 adverse events occurred with a frequency ≥5% (nausea, 13.5%; somnolence, 12.1%; akathisia, 10.1%); 4.8% of patients discontinued due to an adverse event. At LOCF-endpoint, 3.6% of patients had weight gain ≥7%, and 1.5% had weight loss ≥7%. Minimal median changes were observed at endpoint in metabolic lab values.

Conclusions

In adolescents and young adults with schizophrenia, treatment with lurasidone in doses of 37-148 mg/d was a safe, well-tolerated, and effective treatment.

Disclosure

Presenter is an employee of Sunovion Pharmaceuticals Inc. The study summarized in this Abstract was supported by Funding from Sunovion Pharmaceuticals Inc.